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MedTech Global Insights

MedTech Global Insights

By: Ran Chen
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 What's next in the future of health? Welcome to MedTech Global Insights, the podcast dedicated to uncovering the most disruptive technologies and brilliant minds in the medical field. Whether you're an industry professional, investor, or simply curious, subscribe for your dose of cutting-edge information and expert commentary.Copyright 2025 Ran Chen
Episodes
  • Mastering the FDA's Most Rigorous Hurdle: A Pure Global Deep Dive into the Premarket Approval (PMA) Process for High-Risk MedTech

    Mastering the FDA's Most Rigorous Hurdle: A Pure Global Deep Dive into the Premarket Approval (PMA) Process for High-Risk MedTech
    Aug 27 2025
    In this episode of MedTech Global Insights, we tackle the FDA's most stringent regulatory pathway: the Premarket Approval (PMA) process. Designed for high-risk, life-sustaining Class III devices, the PMA is a formidable challenge for even the most innovative MedTech manufacturers. We'll break down the entire journey, from the strategic importance of Pre-Submission meetings to the intense scrutiny of the FDA review and the potential for post-approval study requirements. This episode moves beyond theory to explore the practical realities of a PMA submission. We provide a detailed look at the critical data pillars—non-clinical, clinical, and manufacturing—that form the foundation of a successful application. You'll gain a clear understanding of the steps involved, the common pitfalls to avoid, and the strategic thinking required to bring a high-risk medical device to the U.S. market. **Case Study Highlight:** A company with a groundbreaking implantable device for a rare disease is confident in its data. However, they face a critical challenge: a novel material in their device has no long-term safety precedent. A rejection after a full submission would be catastrophic. Discover how a Pre-Submission meeting with the FDA identified this fatal flaw early, providing a clear path forward and saving the project from failure. **Key Takeaways From This Episode:** 1. What defines a Class III device, and why is the PMA pathway non-negotiable for them? 2. How can a Pre-Submission meeting with the FDA be the most valuable part of your entire regulatory strategy? 3. What are the three non-negotiable data sections that every PMA application must contain? 4. Why does the FDA's 180-day review goal often take much longer in practice? 5. What is the role of an FDA Advisory Committee, and what does it mean if your device has to face one? 6. What is the critical difference between an "Approval" letter and an "Approvable" letter? 7. Are post-approval studies a sign of a weak application, or a standard requirement? 8. How can you prepare your manufacturing facility for the mandatory pre-approval inspection? For more information or to discuss your specific regulatory needs, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    4 mins
  • From Band-Aids to Pacemakers: Pure Global's Ultimate Guide to Medical Device Classification and Navigating Your Regulatory Journey.

    From Band-Aids to Pacemakers: Pure Global's Ultimate Guide to Medical Device Classification and Navigating Your Regulatory Journey.
    Aug 26 2025
    This episode of MedTech Global Insights dives into the most critical first step for any medical device manufacturer: classification. Discover why determining if your device is Class I, II, or III is the single most important decision that dictates your budget, timeline, and path to global market access. We explore the nuances of each classification with real-world examples, from simple Class I devices to life-sustaining Class III implants. Learn about the common pitfalls that can delay your launch by months or even years, and how regulatory requirements for the same device can differ dramatically between major markets like the United States and Europe. A promising scale-up with an innovative infusion pump targeted both the US and EU markets. A subtle difference in classification between the FDA's Class II and the EU's Class IIb designation led to a six-month delay and unexpected costs for additional clinical data. This episode dissects how to avoid such pitfalls. What you'll learn in this episode: - Why is device classification the single most important decision in your regulatory strategy? - What are the key differences between Class I, II, and III devices, with real-world examples? - How can a device be Class II in the US but a higher risk class in Europe, and what does that mean for your budget? - What common mistakes do startups make when classifying their first device? - How do you determine the correct classification for a device that uses novel software or AI? - What are "special controls" and when do they apply to your product? - Why is a Premarket Approval (PMA) for Class III devices so much more challenging than a 510(k)? - How can you leverage your device's classification in one country to accelerate access to over 30 other markets? Contact us at info@pureglobal.com or visit https://pureglobal.com/ for more information.
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    4 mins
  • From Concept to Clearance: Pure Global's Expert Playbook for Avoiding Common FDA 510(k) Pitfalls

    From Concept to Clearance: Pure Global's Expert Playbook for Avoiding Common FDA 510(k) Pitfalls
    Aug 25 2025
    Navigating the FDA's 510(k) premarket notification process is a critical hurdle for most Class II medical device manufacturers seeking entry into the lucrative U.S. market. This pathway is designed to demonstrate that a new device is "substantially equivalent" to an existing one, but the journey from submission to clearance is often complex and fraught with challenges that can lead to significant delays and unexpected costs. This episode of MedTech Global Insights unpacks the three most common and costly pitfalls in the 510(k) submission process. We go beyond the basics to provide actionable insights on predicate selection, performance data requirements, and the nuances of crafting a compelling technical narrative for the FDA, including considerations for the new eSTAR format. Case Study: Imagine a MedTech startup pours its resources into a groundbreaking diagnostic device. They rush their 510(k) submission, only to receive a "Refuse to Accept" letter because their performance testing data didn't directly correlate with their chosen predicate device's data. The project is now stalled for months, investor confidence wavers, and their first-mover advantage evaporates. This episode is your guide to preventing that exact scenario. Key Takeaways: * How can selecting the wrong predicate device jeopardize your entire U.S. market strategy? * What specific performance data does the FDA scrutinize most in a substantial equivalence argument? * Why is the "Indications for Use" statement one of the most critical components of your application? * Are you fully prepared for the mandatory FDA eSTAR submission format and its specific requirements? * What are the top three avoidable mistakes that lead to a "Refuse to Accept" (RTA) letter? * How can you leverage AI and data tools to build a stronger, more defensible 510(k) submission? * What level of detail is required in your device description to avoid unnecessary questions from the FDA? For a smarter path to market clearance, contact us at info@pureglobal.com or visit https://pureglobal.com/.
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    4 mins
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